This week’s Department of Justice “Catch of the Week” goes to Novo Nordisk Inc. On Tuesday, the company agreed to pay $58.65 million to settle charges it violated the False Claims Act and Food, Drug, and Cosmetic Act by failing to comply with the FDA-mandated Risk Evaluation and Mitigation Strategy (REMS) for its Type II diabetes medication Victoza. The New Jersey based pharmaceutical manufacturer is a subsidiary of Denmark’s Novo Nordisk A/S. See DOJ Press Release.
At the time of Victoza’s FDA approval in 2010, the FDA required a REMS to mitigate the potential risk in humans of a rare form of cancer called Medullary Thyroid Carcinoma (MTC) associated with the drug. Under the REMS, Novo Nordisk was required to disclose to physicians the potential risk. If it failed to comply with these disclosure requirements, including requirements to communicate accurate risk information, the drug would be considered misbranded under the law.
According to the government, Novo Nordisk failed to comply with the REMS requirements, providing information to physicians that created the false or misleading impression that the Victoza REMS-required message was erroneous, irrelevant, or unimportant. The government further alleged that the company’s actions led some physicians to be unaware of the potential risks when prescribing Victoza. Furthermore, after a survey showed half of primary care doctors polled were unaware of the potential MTC risk, the FDA required a modification to the REMS. But rather than implement the change, Novo Nordisk allegedly instructed its sales force to provide statements to doctors that further obscured the risk information.
In announcing the settlement, acting DOJ Civil Chief Chad Readler made clear the government’s commitment to ensuring drug makers comply with their disclosure obligations: “When a drug manufacturer fails to share accurate risk information with doctors and patients, it deprives physicians of information vital to medical decision-making.” US Attorney Channing D. Phillips for the District of Columbia echoed this message. “We are committed to holding companies accountable for violating the integrity of the FDA’s efforts to ensure that doctors and patients have accurate information that allows them to make appropriate decisions about which drugs to use in their care.”
The allegations originated in several whistleblower lawsuits filed under the qui tam provisions of the False Claims Act. The whistleblowers who brought these actions will receive a yet-to-be-determined whistleblower award from the proceeds of the government’s recovery.
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